Medical Device Engineer Resume Example

“Medical device engineer with 6 years designing and developing Class II and III medical devices from concept through FDA clearance. Expert in design controls (ISO 13485), risk management (ISO 14971), and verification/validation testing for implantable, diagnostic, and therapeutic devices.”

• Led design and development of a Class II surgical instrument from concept through 510(k) clearance. FDA approval in 8 months
• Managed design control documentation for 5 active device projects. Passed 3 ISO 13485 external audits
• Conducted risk management per ISO 14971 for an implantable cardiac device. Identified and mitigated 200+ hazards to acceptable levels
• Designed V&V testing protocols for a drug delivery device. Completed 500+ test cases across mechanical, electrical, and biocompatibility
• Got the manufacturing defect rate from 3.2% down to 0.4% through DFMEA-driven design changes and tighter process controls
• Responsible for maintaining the design history file (DHF) for each project from requirements through design verification
• Worked with the manufacturing team to transition devices from prototype to production. Wrote work instructions and process specs
• Used SolidWorks for 3D modeling and created engineering drawings for machined and injection molded components
• Coordinated biocompatibility testing with external labs and reviewed results against ISO 10993 requirements

Include these keywords in your resume to pass Applicant Tracking Systems.

• Certified Quality Engineer (CQE)
• RAC (Regulatory Affairs Certification)